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Codman & Shurtleff, Inc. recalls TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil
Recalled January 29, 2014 · FDA recall Z-0788-2014 · Codman & Shurtleff
Hazard
Incorrect instructions for use (IFU). · FDA Class I
Units
3,860
Sold at
Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
Description
Incorrect instructions for use (IFU).
Product
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
Manufacturer(s)
Codman & Shurtleff, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →